Dry drugs such as powdered or lyophilized drugs are typically stored in sealed bottles or vials. In practice, the drug is accessed shortly prior to use by rupturing or piercing the seal provided on the vial. A solvent solution such as saline is then introduced into the vial to reconstitute the powdered or lyophilized drug. Once reconstituted, the drug solution is extracted from the vial for use.
Some prior art vials of powdered or lyophilized drugs include a pierceable membrane secured across the open top of the prior art vial. The membrane is normally pierced by a needle in communication with the solvent. However, care must be taken to avoid the separation of membrane fragments when the seal is pierced, as these may be accidentally delivered to the patient. These seals typically must be pierced each time access to the solvent is desired, heightening the problems associated therewith.
Other prior art vials include rubber stoppers that are removed from or urged into the vial when delivering the solvent for reconstituting the drug. While in general these assemblies work well to safely store a lyophilized drug prior to reconstitution and use, the stoppers normally cannot be accessed once they have fallen into the vial; hence, these vials normally cannot be resealed employing the stopper originally provided. This may be problematic, for instance, where a practitioner may not desire or need to administer the entire dose of reconstituted drug held in the vial; the vial would typically need to be resealed against the ambient environment to preserve the sterility of the drug remaining in the vial. Thus, the structure of these prior art vials is not readily adapted to a vial capable of repeated opening and closing.
Stoppers are normally formulated from materials selected for compatibility with the drug stored in the vial. Hence, the stoppers typically pose no harm to the safety of the drug, whether lyophilized or reconstituted. However, the appearance of a stopper within the interior of the vial often leads to the perception--however flawed--that the drug will be adversely affected by the presence of the stopper. There may also be a perception that the presence of the stopper within the vial impedes good flow of the drug solution.